MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT; VITEK® 2 GP ID CARD

Model Number 03573026131920

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An internal biomérieux investigation was performed.The biomérieux internal reconstituted sample, dap d-01, was subcultured and vitek® 2 gp testing included individual organism suspensions on cards from two (2) different lots, in duplicate.The api® 20 strep kit was also tested.All four (4) vitek® 2 gp cards tested, as well as the api® 20 strep test kit, resulted in excellent identifications of streptococcus mutans.Vitek® 2 gp cards are performing as expected.Review of the aerococcus viridans data against the expected reactions for streptococcus mutans demonstrated three (3) atypical negative reactions (leua, novo, dmne) according to the gp knowledge base contributing to the misidentification.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.The investigation concluded the gp id card lot 2420050103 is performing as intended.Device not returned to manufacturer.

Event Description

A customer in the united states notified biomérieux of a misidentification associated with the vitek® 2 gp test kit involving a cap survey.The customer reported the vitek® 2 gp test kit results were aerococcus viridans; however, the expected result was streptococcus viridans or streptococcus mutans.The customer indicated testing a second sample and got the same results.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient directly associated with the cap survey strain.

Manufacturer Narrative

The inital medwatch report indicated a date of (b)(6) 2017; the date should have been (b)96) 2017.Device not returned to manufacturer.

• Brand Name: VITEK® 2 GRAM-POSITIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GP ID CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6659528
• MDR Text Key: 78377935
• Report Number: 1950204-2017-00196
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 03573026131920
• UDI-Public: 03573026131920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2018
• Device Model Number: 03573026131920
• Device Catalogue Number: 21342
• Device Lot Number: 2420050103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1